MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)

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Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

At visit 1, patients were assessed using the protocol eligibility criteria. Eligible patients continued into an 8 day single-blind placebo washout/run-in period, and then were randomized at visit 3 to 1 of 2 cross-over treatment sequences.

Reporting Groups

Description

MK0249 Then Placebo

These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.

Placebo Then MK0249

These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

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Reporting Groups

Description

MK0249 Then Placebo

These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.

Placebo Then MK0249

These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.

10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.

Placebo

10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.